JP3302687B2 - Male incontinence prevention device - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a male external incontinence prevention device for men. In particular, the present invention relates to a device that applies sufficient pressure to block the urethra along the penis shaft of the abdomen to prevent involuntary urine leakage in incontinent men.

BACKGROUND OF THE INVENTION There are a wide variety of devices and methods for treating male urinary incontinence using external penile devices. Externally applied penis devices with a spring force have been described in two documents.

Urinary Incontinence: Official Document of Control by External Devices, Physical Therapy and Rehabilitation, August 1973, Vol. 54, pp. 376
-378, and an external device for treatment of male urinary incontinence,
See J. Biomechanics, 1972, Vol. 5, pp. 257-260.

 At least four devices are currently on sale.

1) Cunningham Clamp-Bird Home Healthcare Division, CRBard, Inc., Berkeley Heights, NJ 07922; 2) Boum Lucker Clamp-Greenwald Surgical Co., Inc., IN 46405, Lake Station, DeKalb Street, 2688; ) Penowing Clamp-Koken Co., Ltd; Tokyo, Japan 4) Cook Continence Cuff-IN 47460, Spencer, South Main Street 127, Cook Group Company, VPI.

Known patents include U.S. Pat. Nos. 4,102,342; 3,862.
No. 6,611; No. 3,203,421; No. 3,155,096; No. 3,147,754
No. 2,756,753; No. 2,618,270; No. 2,533,924;
And No. 1,728,322.

Many existing devices and methods for treating male urinary incontinence with external penis devices have several disadvantages. One typical problem is that these devices often tend to restrict the blood supply to the penis shaft, which can cause discomfort to the user or, in extreme cases, tissue death Was that. This is due, in part, to the fact that many of these devices constrain the penis shaft between two relatively flat, narrow and rigid members.

Another problem with many existing devices is that the hinge axis is oriented parallel to the axis of the penis shaft. This usually results in a non-uniform pressure zone on the penis shaft. In particular, in devices arranged in a direction parallel to the hinge axis, pressure is applied symbolically on the tissue closest to the hinge.

In addition, another problem with many existing devices is that they are sensitive to tension adjustment because the tension affects the force acting on the penis shaft from the device. Thus, the user may inadvertently tighten the device, limiting the blood supply to the penis.

Many existing devices have been bulky and cumbersome, and have been difficult for users to see. The snaps, hooks, fasteners, inelastic tapes, etc. used to attach the device to the penis shaft were unpleasant and annoying.

In addition, the price of existing devices is generally very high and has not been disposable after a period of use or when they become dirty. Failure to replace these devices due to soiling can lead to reduced health and patient safety.

The present invention solves the above and other problems of the prior art.

SUMMARY OF THE INVENTION The present invention relates to an external male incontinence prevention device including a cradle member having a back arm member having a curved surface and an abdominal arm member having a curved surface. The back and abdominal arm members are arranged coaxially with each other, and an opening is formed in the middle of the back and abdominal arm members. The abdominal arm member is provided with a pressure pad integrally therewith. The cradle member is integrally provided with a hinge for connecting the back and abdominal arm members, and the cradle member is hinged about an axis perpendicular to the axial arrangement of the back and abdominal arm members, thereby allowing the back and abdominal arms to be hinged. The cradle member can be folded in a folded state in which the curved surfaces of the arm members face each other and the pressure pad protrudes into a cavity formed between the opposed curved surfaces of the back and abdominal arms. A strap assembly is used to releasably hold the cradle member in a folded condition.

The male incontinence prevention device for external use of the present invention embodies, in the back and abdominal arm members, a curved portion in which the cylindrical outer shape of the penis shaft is settled. Thus, the force applied to the penis shaft in the present invention acts radially, preventing the blood flow confined in the penis shaft from stopping locally. The back and abdominal arm members contact the back and abdominal arm members on the penis shaft, although the force exerted by the pressure pads, called occlusion pads, is sufficient to prevent leakage of urine from the urethra It is sized and shaped such that increasing the area to some extent reduces the total pressure on the penis shaft.

The present invention relates to a penis shaft axis and a back and abdominal arm member axis arrangement that assist in aligning the back and abdominal arm members and prevent the generation of uneven pressure areas on the penis shaft. It has a vertical hinge axis.

One embodiment of the invention comprises cradle means located on the penis shaft, the cradle means comprising a back arm member and an abdominal arm member substantially coaxially along the long axis of the cradle means. The cradle means also has an opening midway between the back and abdominal arm members.
Since the cradle means is hinged about an axis perpendicular to the longitudinal axis of the cradle means, the cradle means folds between an unfolded state and a folded state in which the back and abdominal arm members face each other. be able to. The back and abdominal arm members are releasably connected to keep the cradle means folded.

The external male incontinence prevention device for external use according to the present invention inserts a penis shaft into the opening between the back and the abdomen, bends the device so that the pressure pad blocks the urethra, puts the device into a folded operating state, and releases the device. It is operated by keeping the device folded on the penis shaft using a flexible strap assembly.

Embodiments of the present invention essentially limit the amount of pressure applied to the penis shaft and provide flexibility to adapt to changes in penis shaft size when the device is mounted.
The ability to adapt to changes in penis shaft size is primarily due to the use of elastic strap assemblies that attach the device to the penis shaft.

In an embodiment, the urethral obstruction pad (pressure pad) integral to the device limits the pressure applied to the urethra to a constant value equal to or greater than the pressure applied to the penis shaft by the back and abdominal arm members. This is accomplished by limiting the size of the obstruction pad projecting from the concave surface of the abdominal arm member. In addition, this feature reduces the likelihood of restricting blood supply to the penis shaft and relatively reduces the force applied to the strap assembly to ensure correct placement of the device on the penis shaft.

An embodiment of the present invention has a flange along the outer edges of the back and abdominal arm members to prevent the device from tightening beyond the contact between the flanges. This limits the maximum pressure on the penis shaft and urethra.

In embodiments of the present invention, the back and abdominal arm members, hinges, and pressure pads are made in one piece to reduce manufacturing costs, so after a period of use or when the device becomes dirty. It can be discarded and replaced when it is, which results in improved body hygiene and patient safety.

Another advantage of embodiments of the present invention is that they can be more compact and invisible to humans than existing devices.
That is.

An embodiment of the present invention is made of a synthetic material made of a semi-rigid polyolefin surface coating fused to a closed cell chemically crosslinked polyethylene foam.
In one embodiment, the composite material is thermoformed to the required profile and then stamped to the correct dimensions. In embodiments, the invention is large enough to hold its shape normally, but with some resilience and flexibility.

Another advantage of embodiments of the present invention is that they use elastic straps to increase user comfort and to allow the back and abdominal arm members to change separation as the penis shaft increases or decreases in diameter. It is that you are.

The above and other advantages and features of the novel product characterizing the invention are set forth in the claims appended hereto and in the features forming a part thereof. However, to further understand the advantages and objects of the present invention and the use thereof, reference numerals have been attached to the main figures of the accompanying drawings and description, and preferred embodiments of the present invention are shown and described in the drawings and the like. ing.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, the same reference numerals indicate the same parts throughout the drawings, and FIG. 1 is a perspective view of one embodiment of an external male incontinence prevention device according to the principles of the present invention.

 FIG. 2 is a plan view of the embodiment shown in FIG.

FIG. 3 is a sectional view taken along line 3-3 in FIG.

FIG. 4 is a perspective view illustrating the arrangement of the device shown in FIG. 1 on a penis.

FIG. 5 shows the FIG. 1 in use, folded on the penis
2 is a perspective view illustrating the device shown in FIG.

FIG. 6 is a cross-sectional view taken along line 6-6 in FIG. 5, illustrating the minimum distance between the back and abdominal arm members.

FIG. 7 is a view similar to FIG. 4 illustrating another method of placing the device on the penis with the concave surface of the device facing away from the user.

FIG. 8 is a view similar to FIG. 5, showing the device in use folded after insertion on the penis in the manner shown in FIG.

Embodiment FIG. 1 shows an embodiment of an external male incontinence prevention device according to the principles of the present invention, which device is designated by the reference numeral 20. The device 20 includes a single cradle member 22 and a strap assembly 24. The cradle member 22 includes a back arm member 26 and an abdominal arm member 28 coaxially.
The back and abdominal arm members 26, 28 have a curved surface 25 with an axially extending flange 27 extending along both sides. An opening 29 sized to receive the penis shaft is formed between the back and abdominal arm members 26 and 28. The abdominal arm member 28 has a bottom wall portion 31 and a curved side wall portion 31a, and has a urethral obstruction pad 3 called a pressure pad.
0 is integrally provided. The cradle member 22 integrally includes a hinge 32 for connecting the back and abdominal arm members 26 and 28. The cradle member 22 is hinged about an axis perpendicular to the longitudinal axis of the back and abdominal arm members 26 and 28 and the penis shaft mounted thereon.

The cradle member 22 has a semi-rigid resin coating layer and a flexible foam layer. The resin layer 34 is disposed on the convex side of the curved surface 25, and the foam layer 36 is disposed on the concave side of the curved surface 25. In one embodiment, the cradle member 22 is a VOLEX extruded composite coated with a composite of a polyolefin surface coating fused to a chemically cross-linked polyethylene foam in a closed cell. Made of. The Volex is available from MAO1843, Lawrence, Shepard Street 100, Vortec Division of Sekisui America. After the material has been thermoformed to the required profile, it is stamped to the correct profile. It is preferable to make cradle members 22 of different sizes suitable for different diameters of the penis shaft.

Cradle member 22 can also be made using other materials and known manufacturing techniques. Examples include, but are not limited to, thermoformed polystyrene with a separate foam pad, and injection or injection molded plastic and / or non-plastic with a separate or integral foam pad.

In the embodiment shown, the strap assembly 24 includes an elastic strap 40 having an elastic backing material 50 and a loop material 52. The elastic strap 40 is attached to the strap 42 immediately before the end portion 44 by ultrasonic welding. The strap 42 is attached to the convex side of the back arm member 26 by a pressure-sensitive mounting layer 46. The strap 42 includes a hook material as an adhesive that can be released from the loop material 52 of the elastic strap 40. In one embodiment of the present invention, the elastic strap 40 is a stretchable belt stretch (VEL-STRETCH: US registered trademark) loop tape, and the strap 42 is Velcro (VELC).
RO: US registered trademark hook tape. The elastic loop tape is ultrasonically welded to the hook tape in the strap profile behind. The elastic strap 40 accommodates changes in the size of the penis shaft, as the back and abdominal arm members 26, 28 move away from each other as the size of the penis shaft increases. Therefore, when the size of the penis shaft is reduced, the back and abdominal arm members 26 and 28 of the elastic strap 40 are attracted to each other.

The strap assembly can also be made using other materials including, but not limited to, inelastic loop tape, elastic webs, foam tape, and elastic or cloth materials. Closure methods include, but are not limited to, snaps, hooks, fasteners, and crimps.

In one embodiment, the integral hinge 32 is a bulged arch 53.
Is formed on the cradle member 22, where the hinge operation occurs. The above-mentioned hinge is preferably formed to have a necessary outer shape when the surface covering 34 and the foam layer 36 bonded thereto are thermoformed.

4-6, the external male incontinence device 20 disposed on the penis shaft 60 is shown in FIG. 4, and the use state folded on the penis shaft 60 is shown in FIG. In use, the user grips the cradle member 22 with the hand 58,
The penis shaft 60 is inserted into the opening 29 from the concave side surfaces of the back and abdominal arch members facing the user's body. Device 22
Is folded at the base of the penis shaft 60 such that the back arch member 26 contacts the back surface of the penis shaft 60 and the abdominal arch member 28 contacts the abdominal surface of the penis shaft 60. Next, the elastic strap 40 of the strap assembly 24 is wrapped around the abdominal arm member 28 and adhered to the strap 42 on the back arm member 26. The elastic strap 40 is applied with less than enough force to securely hold the device 20 in position on the penis shaft 60. When the cradle member 22 is placed in a folded state on the penis shaft 60, the flanges 27 of the back and abdominal arm members 26 and 28
Are separated from each other.

As shown in FIG. 6, when the device is in use, folded over the penis shaft 60, the urethral closure pad 30 is
Located near 62, it provides enough power to block the urethra to prevent inadvertent urine leakage.

To piss or remove the device 20, by removing the elastic strap 40 from the tape 42 on the back arm member 26, the cradle member 22 becomes unfolded,
It can be removed from the penis shaft 60.

7 and 8 show another method of placing the device on the penis shaft 60. In this method, the device 20 is inserted onto the penis shaft 60 with the concave sides of the back and abdominal arm members 26, 28 opposite the body of the user, as shown schematically in FIG. Next, as shown in FIG. 8, the cradle member 22 brings the hinge 32 close to the base of the penis shaft 60, extends the back and abdominal arm members 26, 28 toward the distal end of the penis shaft 60, and folds it to the use position. It is.

While the foregoing description has set forth many features and advantages of the present invention, together with details of the structure and function of the present invention, the foregoing description is limited to the illustrated examples and includes the terms defined in the appended claims. To the fullest extent shown in a broad and general sense, details may be varied, particularly with respect to the shape, size, and arrangement of the components, within the principles of the present invention.

──────────────────────────────────────────────────続 き Continued on the front page (72) Inventor Tim Gerald Double Minnesota 55331 Deep Havun Lakeview Avenue No. 20400 (56) Reference JP-A-58-175554 (JP, A) US Patent 3203421 (US, A) U.S. Pat. No. 3,866,611 (US, A) U.S. Pat. No. 2,756,753 (US, A) U.S. Pat. No. 3,147,754 (US, A) U.S. Pat. No. 4,534,353 (US, A) U.S. Pat. ) Surveyed field (Int.Cl. ⁷ , DB name) A61F 5/37

Claims (10)

(57) [Claims] 1. A cradle member comprising a back arm member having a curved surface and an abdominal arm member having a curved surface, wherein the back and abdominal arm members are located coaxially with each other. An opening is formed in the middle of the arm member, the abdominal arm member integrally has a pressure pad, the cradle member integrally has a hinge connecting the back and the abdominal arm member, and the cradle member has The hinge is hinged on an axis perpendicular to the axis of the curved surface of the back and abdominal arm members, whereby the pressure pad protrudes into a cavity formed between the opposed curved surfaces of the back and abdominal arm members. A cradle member that can be folded in a folded state in which the curved surfaces of the back and abdominal arm members are opposed to each other; b) unfolding the cradle member in the folded state To be able to and strap assembly for holding, male incontinence prevention device for external use made of. 2. The strap assembly according to claim 1, wherein said strap assembly includes a piece of elastic tape attached immediately before one end to said cradle member, and a loop material releasably attachable to a hook material attached to said cradle member. Equipment. 3. The apparatus of claim 1 wherein said cradle member comprises a polyolefin surface coating fused to a closed cell chemically crosslinked polyethylene foam. 4. The apparatus of claim 3 wherein said cradle member is thermoformed. 5. The apparatus of claim 1 wherein said cradle member has a top semi-rigid resin layer attached to a bottom foam layer. 6. The apparatus of claim 1 wherein said back and abdominal arm members include flange means along their edges to limit the force applied to the penis shaft by said back and abdominal arm members. 7. The strap assembly has an elastic member for holding the back and abdominal arm members in a folded state, and the elastic member is provided for the back and abdominal arm members as the diameter of the penis shaft increases or decreases. 7. The device of claim 6, wherein the separation is variable. 8. The apparatus of claim 1, wherein said hinge is arched on said cradle member. 9. The apparatus of claim 1 wherein said cradle member is made of one piece. 10. A cradle means disposed on a penis shaft, said cradle means having a back arm member and an abdominal arm member coaxial with each other along a longitudinal axis of said cradle means. The cradle means has an opening in the middle of the back and abdominal arm members so that the cradle means can be folded between an unfolded state and a folded state in which the back and abdominal arm members face each other. The cradle means is hinged about an axis perpendicular to the longitudinal axis of the cradle means, and when the cradle means is mounted on a penis shaft, the axis hinged to the cradle means is at the axis of the penis shaft. Cradle means that is perpendicular to the back; and b) the back and belly to hold the cradle means in a folded position. A strap assembly for connecting the arm member releasably, male urinary incontinence prevention device of the external consisting.